College of American Pathologists
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  Analyte Specific Reagents Fact Sheet


Page last updated: October 4, 2003


The start of new Food and Drug Administration requirements for laboratories using analyte specific reagents (ASRs). ASRs are reagents composed of chemicals or antibodies that may be thought of as the "active ingredients" of in-house developed tests and purchased from manufacturers under this label.

The FDA defines ASRs as "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens."

The majority of ASRs are exempt from FDA approval or clearance.

Manufacturers of ASRs are prohibited from making claims of analytical or clinical performance.

The FDA very clearly distinguishes ASRs from immunohistochemistry (IHC) reagents (final rule effective Aug. 17, 1998). The FDA defines IHCs as "in vitro diagnostic devices...intended to identify, by immunological techniques, antigens in tissue or cytologic specimens." Unlike ASRs, IHCs are labeled by manufacturers with directions for use and performance indications.


Beginning November 23, 1998.


Laboratories using ASRs are required to include a disclaimer on test reports that reads: "This test was developed and its performance characteristics determined by (laboratory name). It has not been cleared or approved by the U.S. Food and Drug Administration."

The College recommends, and the FDA has agreed to, the use of additional clarifying report language by laboratories stating that ASR use does not require FDA approval.

Promotional and advertising materials for ASRs shall include the statement: "Analyte Specific Reagent. Analytical and performance characteristics are not established." Also, claims cannot be made regarding analytical or clinical performance.

Laboratories using products labeled by manufactures as IHC reagents are not required to use a disclaimer statement.


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